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Citalopram for Reflux Hypersensitivity and Functional Heartburn

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ClinicalTrials.gov Identifier: NCT03499171
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Prof Dr Jan Tack, Universitaire Ziekenhuizen Leuven

Brief Summary:
Citalopram is a drug used in the treatment of depressive episodes and belongs to the group of selective serotonin reuptake inhibitors (SSRI). Serotonin is an important neurotransmitter predominantly found in the brain and the gastrointestinal tract. Serotonin is associated with psychological disorders, including anxiety and depression, and emotion regulation and it has been shown that anxiety and depression are associated with increased severity of GERD-related symptoms. Citalopram and other SSRI's elevate the concentration of serotonin by blocking the reabsorption into the presynaptic neuron and thereby increasing the level of serotonin available to bind the postsynaptic receptor. A recent study showed beneficial effects of citalopram in patients with reflux hypersensitivity. However, there was no objective measurement for reflux nor esophageal sensitivity during the treatment period. Moreover, the effect of citalopram in patients with functional heartburn has not been studied so far. Therefore, the inevestigators will conduct a randomized, parallel, placebo-controlled study to evaluate the efficacy of citalopram on the improvement in symptom severity, reflux parameters and esophageal sensitivity. 50 patients with reflux hypersensitivity and 50 patients with functional heartburn will receive either placebo or citalopram (Cipramil®) 20 mg as an add-on for a period of 8 weeks. Symptom severity will be assessed by a validated reflux questionnaire (ReQuest questionnaire and diaries), reflux parameters by performing a 24 hour impedance-pH monitoring and esophageal sensitivity using the multimodal esophageal stimulation paradigm

Condition or disease Intervention/treatment Phase
GERD Drug: Citalopram 20mg Drug: Placebo Oral Tablet Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Placebo-controlled Trial With Citalopram for the Treatment of Typical Reflux Symptoms in Patients With Reflux Hypersensitivity or Functional Heartburn With Incomplete Proton Pump Inhibitor Response
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy GERD Heartburn

Arm Intervention/treatment
Experimental: Citalopram
20mg, once a day
Drug: Citalopram 20mg
Citalopram is taken once a day as an add-on to PPI treatment (2x/d).

Placebo Comparator: Placebo
Once a day
Drug: Placebo Oral Tablet
Placebo is taken once a day as an add-on to PPI treatment (2x/d)




Primary Outcome Measures :
  1. change in number of reflux episodes [ Time Frame: 8 weeks ]
    The primary efficacy endpoint will be the change in number of reflux episodes assessed by 24 hour impedance-pH monitoring.


Secondary Outcome Measures :
  1. change in reflux parameters [ Time Frame: 8 weeks ]
    change in reflux parameters (number of reflux episodes with a high proximal extent, volume exposure) assessed by 24 hour impedance-pH monitoring,

  2. change in esophageal sensitivity [ Time Frame: 8 weeks ]
    change in esophageal sensitivity assessed by multimodal esophageal stimulation procedure

  3. change in symptom severity [ Time Frame: 8 weeks ]
    change in symptom severity assessed by validated reflux questionnaires (ReQuest questionnaire and diaries). Patients will have to indicate the symptom occurence and symptom severity on a scale. Two words, on each site of the scale indicate their symptom severity (on the left "totally not present" on the right "very strong present"). A higher score represents a worse outcome.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 to 65 years old.
  2. History of typical GERD symptoms during PPI treatment, at least 3 times per week for 12 weeks.
  3. Daily intake of PPI treatment 12 weeks prior to inclusion, with at least 8 weeks of b.i.d. therapy (at least 2*20mg of omeprazole or equivalent).
  4. Sexually active women of child bearing potential participating in the study must use a medically acceptable form of contraception. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception.
  5. Subjects must be capable of understanding and be willing to provide signed and dated written voluntary informed consent before any protocol-specific screening procedures are performed.

Exclusion Criteria:

  1. Endoscopic signs of severe erosive esophagitis (≥ grade B, Los Angeles classification) on endoscopy performed during PPI treatment in the 6 months prior to screening.
  2. Systemic diseases, known to affect esophageal motility.
  3. Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
  4. QT c>450 ms
  5. Treatment with SSRI's prior to the start of the study.
  6. Concomitant use of medications such as: anticholinergics, tricycle antidepressants, baclofen and prokinetics.
  7. Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
  8. Major psychiatric disorder.
  9. Absence of PPI intake for at least 2 consecutive days in the 2 weeks prior to the screening.
  10. Pregnancy or breast feeding.
  11. History of poor compliance. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
  12. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499171


Contacts
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Contact: Hannelore Geysen +32 (0)16 324921 hannelore.geysen@kuleuven.be

Locations
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Belgium
UZ Leuven Recruiting
Leuven, Belgium, 3000
Contact: Hannelore Geysen    +32 (0)16 324921    hannelore.geysen@kuleuven.be   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

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Responsible Party: Prof Dr Jan Tack, Prof. Dr., Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03499171     History of Changes
Other Study ID Numbers: S61111
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hypersensitivity
Heartburn
Immune System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Citalopram
Dexetimide
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents